MAUDE Adverse Event Report: BAUSCH + LOMB 25G BI-B COMBINED ELITE W WF; UNIT, PHACOFRAGMENTATION

Model Number	SE5525WVB
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Hyphema (1911)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been requested.Manufacturing and sterilization records were reviewed and found to be acceptable.This investigation is ongoing.
Event or Problem Description
It was reported by the user facility in the united kingdom that the infusion line was not retaining in the trocar and led to a hemorrhage.Surgery was extended 15-30 minutes for additional treatment.
Additional Manufacturer Narrative
As new information has been reported the event is no longer deemed to be a serious injury as the hemorrhage was very small and is very often a complication during vitreoretinal surgery.This event no longer meets reportability requirements.
Event or Problem Description
Additional information received the user facility reports that they just put bottle height up to control the hemorrhage.No additional anasthesia was required and followup on the patient is good the hemorrhage did not spread.

• Brand Name: 25G BI-B COMBINED ELITE W WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 19003720
• Report Number: 0001920664-2024-00045
• Device Sequence Number: 20943889
• Product Code: HQC
• UDI-Device Identifier: 00757770059768
• UDI-Public: (01)00757770059768(17)250101(10)X4666
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2025
• Device Model Number: SE5525WVB
• Device Lot Number: X4666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown